title: A phase II trial evaluating two schedules of sagopilone (ZK-EPO), a novel epothilone, in patients with platinum-resistant ovarian cancer.
abstract: BACKGROUND
  Sagopilone, the first fully synthetic epothilone, has shown promising preclinical activity in tumour models. This open-label randomised phase II study investigated two infusion schedules of sagopilone in women with ovarian cancer.
  
  
  METHODS
  Women with ovarian cancer recurring within 6 months of end of last platinum-containing treatment received sagopilone 16 mg/m(2) as a 3- or 0.5-h i.v. infusion every 21 days for up to 6 weeks.
  
  
  RESULTS
  Sixty-three patients received sagopilone as a 3-h (n=38) or 0.5-h (n=25) infusion. There were nine confirmed tumour responses [by modified RECIST (n=8) and by Gynecologic Cancer Intergroup CA-125 criteria (n=1)] in 57 patients assessable for efficacy overall [three (13%) with 0.5-h and six (18%) with 3-h infusions]. The 0.5-h arm was closed when it failed to meet its target efficacy. Main drug-related adverse events were peripheral sensory neuropathy (73%; 16% grade 3), nausea (37%; 2% grade 3), fatigue (35%; 3% grade 3) and arthralgia (30%; 5% grade 3). Overall incidence of peripheral sensory neuropathy was similar in both treatment arms, with no grade 4 neuropathy events. No acute allergic infusion reactions were observed.
  
  
  CONCLUSIONS
  Sagopilone is effective, with balanced tolerability, in patients with recurrent platinum-resistant ovarian cancer.
authors.affiliation: Medical Oncology, Mount Vernon Cancer Centre, Northwood. Electronic address: grustin@nhs.net.
authors.forename: G
authors.initials: G
authors.lastname: Rustin
authors.affiliation: Department of Clinical Oncology, Beatson Oncology Centre, Gartnavel General Hospital, Glasgow.
authors.forename: N
authors.initials: N
authors.lastname: Reed
authors.affiliation: School of Cancer and Enabling Sciences, University of Manchester and Christie Hospital, Manchester.
authors.forename: G C
authors.initials: GC
authors.lastname: Jayson
authors.affiliation: Department of Oncology, UCL Hospitals and UCL Cancer Institute, London.
authors.forename: J A
authors.initials: JA
authors.lastname: Ledermann
authors.affiliation: Clinical Oncology, Velindre NHS Trust, Cardiff.
authors.forename: M
authors.initials: M
authors.lastname: Adams
authors.affiliation: Department of Medical Oncology, St James's Institute of Oncology, St James's University Hospital, Leeds.
authors.forename: T
authors.initials: T
authors.lastname: Perren
authors.affiliation: Arden Cancer Research Centre, University Hospitals Coventry and Warwickshire, Coventry.
authors.forename: C
authors.initials: C
authors.lastname: Poole
authors.affiliation: Department of Oncology, Princess Royal Hospital, Hull.
authors.forename: M
authors.initials: M
authors.lastname: Lind
authors.affiliation: Clinical Oncology, Derbyshire Royal Infirmary, Derby.
authors.forename: M
authors.initials: M
authors.lastname: Persic
authors.affiliation: Clinical Oncology, The Royal Surrey County Hospital, Guildford.
authors.forename: S
authors.initials: S
authors.lastname: Essapen
authors.affiliation: Gynaecology Unit, The Royal Marsden NHS Foundation Trust, London.
authors.forename: M
authors.initials: M
authors.lastname: Gore
authors.affiliation: UCL Cancer Institute, London.
authors.forename: H
authors.initials: H
authors.lastname: Calvert
authors.affiliation: Bayer plc, Newbury, UK.
authors.forename: C
authors.initials: C
authors.lastname: Stredder
authors.affiliation: Global Medical Development Oncology, Bayer Schering Pharma AG, Berlin, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Wagner
authors.affiliation: Global Medical Development Oncology, Bayer Schering Pharma AG, Berlin, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Giurescu
authors.affiliation: Gynaecology Unit, The Royal Marsden NHS Foundation Trust, London.
authors.forename: S
authors.initials: S
authors.lastname: Kaye
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D052160:Benzothiazoles / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D034261:Epothilones / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy*
chemical_list: D000970:Antineoplastic Agents; D052160:Benzothiazoles; D034261:Epothilones; C530494:sagopilone